FDA.reportPublic FDA data

Leica Microsystems NC, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30068096953006809695Leica Microsystems NC, Inc.1N2026-01-014222 Emperor Blvd Suite 390 Durham NC US 27703
30068096953006809695Leica Microsystems NC, Inc.1N2020-04-254222 Emperor Blvd Suite 390 Durham NC US 27703

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2827821998945142K162783EnFocus 2300, EnFocus 4400OBO2016-12-09
2827821181537441K150722EnFocus 2300, EnFocus 4400HLI2015-12-02
881081520719325K150722EnFocus 2300, EnFocus 4400HLI2015-12-02
881081791953058K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)HLI2012-05-11
881081896629300K063343BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEMHLI2006-12-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HLI42015-12-02
OBO12016-12-09